MAUDE Adverse Event Report: BIOMET MICROFIXATION TEMPOROMANDIBULAR JOINT SMALL LEFT FOSSA COMPONENT; FOSSA IMPLANT

Model Number N/A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Swelling (2091); Dizziness (2194); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of the device history records show that the lot was released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.The product remains implanted in the patient and therefore will not be returned for an evaluation.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.This is report 1 of 2 for the same event.Report 2 of 2 is reported on mfr #0001032347-2016-00311.

Event Description

A patient reported experiencing a lot of pain, facial swelling on the left side, chronic sinus infections of the left side, fevers, dizzy spells, issues with hearing on the left side, and her ear gets bright red sometimes which makes her (and her surgeon) think she is allergic to the implant (although it is a titanium mandible).The patient adds that she feels like the implant is dislocated, like "maybe a piece of the fossa broke" since her "bite changes frequently." additionally, she reported that her "range of motion is not correct by about 50 to 55 degrees;" and that she has "a feeling as if the poly component has 'popped out' of socket." the patient states she may have a biofilm infection and received 3 doses of antibiotics (levaquin, vibramyacin, and cefdinir).She states her surgeon recommended taking the implant out but the patient answered him that she wanted to do more research first.The patient states the surgeon suspects that maybe she might also have an infection in the joint and would need to take a culture to confirm.

Manufacturer Narrative

Though no product was returned, a device evaluation was conducted.According to the evaluation, the product identity has been confirmed.The patient states that she has been diagnosed with a biofilm infection of her left joint.A biofilm infection is a chronic infection of a particular area.The complaint was confirmed as the patient has preexisting pain and a chronic biofilm infection of the left temporomandibular joint.The allegations of swelling, dizzy spells, issues with hearing, and fevers, can all be attributed to the biofilm infection the patient has.The antibiotics were used to combat the existing biofilm infection and not due to the implant.Chronic pain and range of motion can be attributed to the patients existing condition as the patient is unlikely to regain full range of motion, but will see improvements to both range of motion and pain based on the preexisting condition before surgery.There are no indications of manufacturing defects.

• Brand Name: TEMPOROMANDIBULAR JOINT SMALL LEFT FOSSA COMPONENT
• Type of Device: FOSSA IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 5743360
• MDR Text Key: 47995344
• Report Number: 0001032347-2016-00310
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 24-6563
• Device Lot Number: 628720B
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2016
• Initial Date FDA Received: 06/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention